CFPP 01-01 Part C Steam Sterilization

CFPP 01-01 Management and decontamination of surgical instruments: Part C Steam sterilization
18
Steam supply
3.1 There should be a continuous supply of saturated
steam for steam sterilization.
3.2 There is a need to specify, for all processes, the
quality of steam entering the sterilizer chamber and
coming into contact with the load. This section
defines a suitable specification for the steam supply.
3.3 The critical variables are the dryness of the steam
(expressed as a dryness value), superheat and the
level of non-condensable gases (expressed as a
fraction by volume). Before a newly installed or
replaced sterilizer is handed over to the User, the
steam supply should be examined and tested.
3.4 Users should note that where the steam is supplied
from the mains, quality can vary greatly during the
course of a working day. In many hospitals, steam
demand is greatest early in the morning when
SSDs, kitchens and laundries can start work at the
same time. Care should be taken to sample the
steam at times throughout a typical working day to
gauge the likely range of steam quality. The trend
to 24hour production may require different
sampling patterns.
3.5 European Standards supporting the EU Directives
on medical devices (see paragraph 1.17,
Specification and contract) place requirements on
the quality of the environment in contact with a
medical device (BS EN ISO 17665) and specifically
give guidance on the chemical quality of steam (BS
EN 285).
Engineering considerations
3.6 Steam is generally obtained from the hospital mains
or dedicated steam generators.
3.7 In each case, the delivery of high-quality steam
depends on careful engineering.
Capacity
3.8 The steam service should be designed to meet the
maximum steam demand of the sterilizer for short
periods, while keeping the fall in pressure before
the final pressure-reducing system to not more than
10%. A single porous-load sterilizer of up to 600 L
should use a boiler of at least 50 kW and storage to
meet a peak demand of 125 kW for 15 min. The
effect on the steam supply of the demands of other
sterilizers and equipment should be carefully
considered. Other options are available (for
example steam generators, steam/steam generators).
Pipework
3.9 Except for vertical rises between floors, steam
pipework should be designed so that any
condensate flows by gravity in the same direction as
the steam. This general principle applies equally to
steam mains, branch connections and pipework on
the sterilizer itself. Air vents and steam traps should
be fitted at each vertical rise. Care should be taken
to trap, drain and return any condensate which
may be collected in pockets in the pipework. Dead-
legs should be avoided.
3.10 The accumulation of condensate in the periods
when the sterilizer is not in operation should be
avoided, particularly in any part of the pipework
and fittings between the take-off from the manifold
and the sterilizer chamber. This can be achieved by
the correct declination of each portion of pipework
and by adequate trapping throughout the steam
distribution system.
3.11 Figure 2 shows a suggested layout for the steam
service in the plantroom. The supply main should
terminate in an adequately vented and trapped
manifold, not less than 150 mm nominal bore, that
is of adequate length for any future expansion. A
vent, with a cooling pot, should be installed on the
manifold upstream of the supply pipes to
individual sterilizers. A pressure gauge should be
fitted to the manifold.
3.12 The steam pressure within the manifold should be
set to a value within the acceptable range of supply
pressure to the sterilizer as specified by the
manufacturer.
3 Steam plant
3 Steam plant
19
3.13 If the sterilizer manufacturer has not already fitted
them, an appropriate and correctly installed
separator and steam trap should be fitted upstream
of the sterilizer reducing valve. Advice should be
sought from the CP(PS).
3.14 Three suitable test connections should be provided
on the supply pipe to each sterilizer to permit the
attachment of a needle valve, a pitot tube and a
temperature sensor as shown in Figure 2. Safe
access should be provided for the CP(D) to carry
out steam quality tests including the provision of
convenient cooling water and electrical supplies for
test purposes.
3.15 Careful attention should be paid to the location of
all pressure relief valves to ensure that the sterilizer
is properly protected. Relief valves and their
discharge pipes should be large enough to prevent
the pressure in the supply pipe from the manifold
rising to more than 10% above the design pressure
for the manifold.
3.16 The discharge pipe should terminate outside the
building in a safe, visible position not affected by
frost. Any rising discharge pipe should be fitted
with a drain at the lowest point to prevent the
accumulation of condensate. A tell-tale pipe of
narrow bore should be connected to the drain point
and should terminate inside the plantroom.
Materials
3.17 To meet the purity standard for sterilizers, parts in
contact with steam entering the chamber should be
constructed from low-carbon or stabilised stainless
steel.
Figure 2 Layout of plantroom steam service
Part view on
arrow A
150 mm O/D manifold
to be full length of plantroom
Section A-A
400mm
minimum
Pipe to safe
discharge
Air vent fitted
near to seam element
100 mm diameter
expansion tube
Steam
entry
Relief valve
discharge to safe
position
To pressure balance
connection on first stage
reducing valve
See
detail
B
A
Fall
35 mm O/D
100 mm diameter
expansion tube
Pipe to safe
discharge
Air vent fitted
with near to
steam element
06 bar
pressure gauge
with cock and
siphon
100 mm minimum
drain pocket
Blow down cock
discharge to safe
position
Gas sampling
(1/4 BSP socket)
Pitot connection
(1/4 BSP socket)
Pitot with 6 mm
tube extension
for flexible
connection
To sterilizer
via separator
trap set and
strainer
Connection for steam
pitot (must be concentric)
Sterilizer steam
manifold
Flange
Flange on
manifold
Steam
flow
Detail B
Sealing
washer
Flange dip pipe
insert to centre
To trap set Steam temperature
measurement
(1/4 BSP socket)
A 300 mm
minimum
To trap set
fitted with near
to steam element
20
Dryness
3.18 Saturated steam is required for sterilization so that
sufficient energy is transferred to the load upon
condensation in order to achieve the required
lethality. The dryness of the steam is therefore of
vital importance; too little moisture carried in
suspension may allow the steam to become
superheated during expansion into the chamber
and thus impair sterilization, while excess moisture
may deliver insufficient energy to the surface of the
load to be sterilized, and additionally may cause
damp or wet loads and uneven temperature
distribution.
3.19 Steam dryness is traditionally characterized by a
dryness fraction, but this is not appropriate for
sterilizers because the method of measurement is
difficult and requires a constant flow of steam. The
low-volume sampling technique described in the
steam dryness test (see Steam dryness test) cannot
be regarded as measuring a true dryness fraction
because the sample is taken from the centre of the
steam supply pipe, and condensate flowing along
the pipe wall is not collected. Consequently the
term dryness value is used, where 1.0 represents
dry, saturated steam. This method is used to
determine whether performance problems could
occur during testing and routine production. It is
suitable for sterilizer installations because control
valves and pipe services fitted to the sterilizer
considerably reduce the amount of condensate
entering the sterilizer chamber such that the sample
has a similar amount of free condensate to the
steam in the chamber.
3.20 European Standards require that sterilizers be
designed to operate with steam having a dryness
value of not less than 0.9 when measured in
accordance with the steam dryness test described in
paragraph 3.233, Steam dryness test. For metal
loads, the dryness value should not be less than
0.95. In practice, problems are unlikely to occur if
the pressure reduction through the final pressure-
reducing system is of the order of two to one.
3.21 Deviations from this specification are likely to
cause the following problems:
a. wet loads, resulting from too low a dryness
value;
b. superheating, resulting from either too high a
dryness value before the pressure-reducing stage,
or excessive pressure reduction through a valve
or other restriction in the pipework
(superheating may be severe if both conditions
are present simultaneously);
c. difficulties with operation of the pressure-
reducing system, resulting from a low pressure-
reduction ratio, water hammer, water logging,
dirt and other carry-over.
Excessive moisture
3.22 Possible causes of excessive moisture, where
droplets of water are present in the steam and at the
same temperature as that of the steam, are:
a. steam pipes or manifolds might be incorrectly
sloped and drained;
b. the sterilizer might be supplied from an
inadequately drained and vented dead-leg rather
than a live steam main;
c. the pipework between the boiler and the
sterilizer might be insufficiently insulated,
causing excessive condensation of the supply
steam.
3.23 If wet steam continues to be a problem, priming
might be occurring in the boiler, causing water
droplets to be delivered in the steam. Modern
compact and high rated boilers and steam
generators are particularly sensitive to the quality of
feed-water treatment and are much more likely to
prime than boilers of traditional design. Priming or
foaming (which results in carry-over of the boiler
water) can be caused by any of the following:
incorrect feed-water treatment;
boiler water level being set too high;
forcing a boiler which needs internal cleaning;
violent boiling under fluctuating load
conditions;
a high level (typically 2000 ppm) of TDS.
3.24 The relationship between water injection timing
and steam generation should also be checked in
order to reduce water slugging of the system.
Superheating
3.25 Superheated steam is an unsuitable medium for
moist heat sterilization and can cause failure to
sterilize, scorching of textiles and paper, and rapid
deterioration of rubber. Superheat conditions
within the load and chamber may result from
adiabatic expansion, exothermic reaction or both.
3 Steam plant
21
3.26 European Standards require that the superheat in
free steam at atmospheric pressure should not
exceed 25C when measured by the superheat test.
3.27 Superheating caused by adiabatic expansion is
usually the result of an excessive reduction in
pressure through a throttling device, such as a
pressure reducing system or a partially closed main
steam valve. It is unlikely to be of significance in
the circumstances normally encountered in hospital
steam distribution systems, but superheating may
arise if the main steam supply is dry, or the pressure
is unusually high before the throttling device. This
superheat can sometimes be avoided by measures
that reduce the dryness value of the steam at the
inlet to the sterilizer pressure reducing system. The
reduced pressure ratio will minimise the effect of
the expansion through it.
3.28 Superheating arising from exothermic reaction may
occur during sterilization as a result of rehydration
of exceptionally dry hygroscopic material.
Non-condensable gases
3.29 Non-condensable gases (NCGs) are defined as
gases that cannot be liquefied by compression
under the range of conditions of temperature and
pressure used during the sterilization process. Low
levels of NCGs contained in steam supplied to
sterilizers can markedly affect the performance of
the sterilizer and the efficacy of the process, can
cause chamber overheat and can lead to
inconsistencies in the performance of air detectors
and failure of the Bowie-Dick test (see paragraph
4.81, Operation of porous-load sterilizers). The
major NCGs are air and carbon dioxide.
3.30 European Standards require that sterilizers be
designed to operate with steam having a fraction of
NCGs not exceeding 3.5% by volume of gases to
steam that has been condensed when measured by
the method described in the non-condensable gas
test (see paragraph 3.207, Non-condensable gas
test).
3.31 The main source of NCGs in the steam supply is
the boiler feed-water, and the level will be greatly
influenced by the water treatment employed. In
some cases a study by a water treatment specialist
will be necessary. The study should cover analysis of
the water, venting and the blow-down regime
required in order to ensure protection of the boiler
against corrosion whilst minimising the
entrainment of NCGs in the steam supply.
3.32 If anti-foaming agents and oxygen-scavenging
agents (such as sodium sulphite) are used, checks
should be made to ensure that the dosages are
accurate.
3.33 Water-softening treatment should be employed to
prevent the formation of scale. A base-exchange
softener will reduce scale but will also produce
bicarbonate ions, which will break down into
carbon dioxide in the boiler and give rise to an
increase in NCG levels.
3.34 In order to drive off dissolved air, carbon dioxide
and other NCGs in the boiler feed-water should be
degassed before use by heating in a vented tank (a
hot well). This will also break down bicarbonate
ions, driving off further carbon dioxide. For the
degassing to be effective, the temperature of the
feed-water should not fall below 80C at any time.
The following measures should be adopted:
a. pipework returning condensate to the hot well
should be well lagged to keep the condensate
hot;
b. the amount of cold make-up water in the hot
well should at no time exceed 15% (the rest
being returned condensate), since new water
will both lower the temperature and introduce
further NCGs;
c. the water in the hot well should be kept well
mixed. This may be achieved by locating the
feed-water inlet on the opposite side of the tank
from the outlet, and by arranging for the feed-
water to be sparged from the inlet through a
number of small openings.
3.35 In very hard water areas the level of NCGs may still
be high despite these measures. Where this is the
case, the feed-water should undergo dealkalisation
treatment, and the high temperatures in the hot
well should be maintained. Treatment with filming
amines is not permitted for sterilization
applications.
3.36 Users should note that, even with a well-designed
system, the level of NCGs can be affected by
competing demands on the steam service. For
example, where a central steam boiler supplies both
a sterilizer unit and a laundry through the same
distribution system, the level of NCGs in the steam
at the sterilizer may rise when the laundry demand
is high. This is the result of an influx of cold make-
up water into the hot well. Paradoxically, in some
installations the NCG level may also rise when
steam demand is low. In this case, NCGs that
22
would normally be removed by the laundry are
being carried through to the sterilizer.
3.37 Some other causes of the presence of NCGs in the
steam are as follows:
a. the boiler might be priming (see paragraph
3.18, Dryness);
b. air might be being drawn into the system either
through the boilers feed-pump glands or
through a leak in the steam pipework between
the boiler and the sterilizer;
c. steam pipework might be inadequately vented;
d. where NCGs are found in the sterilizer chamber
during a production cycle:
(i) there might be an air leak into the chamber;
(ii) packaging materials, for example certain
boxes, inks, adhesives, labels or trays, might
be liberating gases.
Steam quality responsibilities
3.38 The AE(D) should be able to advise the User on all
aspects of the production and use of steam for
sterilization.
3.39 The User should:
a. appreciate the nature of contaminants in steam
supply (especially pyrogens), their possible
adverse effects and their sources;
b. understand the requirements of legislation on
medicinal products and medical devices as
regards sterilization;
c. be familiar with the current and impending
standards on steam sterilization and their
implications for steam quality;
d. understand the difference between process
steam, and steam as defined in BS EN 285 and
BS EN ISO 17665, and the appropriate
applications of each;
e. understand the rationale for the steam
specification;
f. understand the engineering principles required
for the delivery of steam and how they might be
realised for mains steam, dedicated steam
generators and sterilizers with internal
reservoirs;
g. with appropriate advice, decide whether steam
is required for any sterilizer unit and if so, what
is the best means of achieving it;
h. after the required engineering work is complete,
be satisfied that the chosen system is capable of
supplying steam;
j. appoint a suitable laboratory and liaise with
them regarding the analysis of steam and feed-
water samples;
k. arrange for the steam supply to be formally
validated;
m. on completion of the validation tests, confirm
that the sterilizer is fit for use with the steam
supply;
n. arrange for periodic maintenance of any steam
generating and distribution plant under the
Users control;
p. arrange for periodic tests of the steam quality at
intervals coinciding with periodic tests on the
sterilizer.
3.40 The CP(D) should:
a. understand and be trained in the operation of
the apparatus for taking samples of steam
condensate for field analysis (see paragraph
3.157, Sampling);
b. be aware of the correct procedures for collecting,
preserving and handling samples;
c. be trained in the measurement of electrical
conductivity of water samples using a portable
meter;
d. be trained and aware of the guidance in
paragraphs 3.2513.262, Operation and
maintenance of steam generators if maintaining
steam generators.
3.41 The Microbiologist (Decontamination) should be
able to advise on all microbiological aspects of
steam.
Contamination in steam supplies
Introduction
3.42 Recent years have seen a growing awareness of the
need to improve the quality of steam used for
sterilization, due in part to regulatory requirements
for medicinal products and medical devices, but
also by increasing concern about the potential
harmful effects on patients of even minute
quantities of contaminants. BS EN ISO 17665
requires that impurities in any medium in contact
3 Steam plant
23
with the medical device be known, and limits of
acceptability identified.
3.43 This section discusses the adverse effects that
impurities in the steam supply can have on
patients, equipment and the sterilizer itself. It
identifies the products most likely to be susceptible
to contamination and reviews the means by which
various contaminants find their way into steam for
sterilization.
Why does contamination matter?
3.44 Quality assurance in the manufacture of medicinal
products and medical devices requires that the
quality of the steam used in sterilization should be
known and controlled. There are a number of
specific contaminants known to have adverse effects
and whose presence in steam is therefore
undesirable.
Adverse effects on patients
3.45 Several contaminants are known to have adverse
effects on patients.
a. Metals: Many of these are toxic (some are
cumulative poisons) and therefore their presence
is undesirable. Metals of particular concern
include cadmium, lead, mercury and other
heavy metals.
b. Organic compounds: Many of these are
biologically active and therefore undesirable.
The chief compounds of concern are filming
amines and other chemicals that may be used in
boiler treatment.
c. Microorganisms: This includes all pathogens
and all Gram-negative bacteria (which are
sources of pyrogens).
d. Pyrogens: These are bacterial endotoxins,
predominantly derived from Gram-negative
bacteria, which can cause severe reactions when
administered intravenously.
e. Particulate material: Solid particles can lead to
a number of adverse effects if injected into the
body.
3.46 Pyrogens are of particular concern because, unlike
other contaminants, there are no controls on the
levels of pyrogens in public water supplies from
which steam is generated. They are extremely heat-
stable and are only destroyed after prolonged
exposure to high temperatures (3 h at 180C or
30min at 250C). They are not inactivated by any
of the standard sterilization processes employed for
medical devices and medicinal products. Control of
pyrogens should be a priority for steam sterilization
(see also paragraph 3.263, Pyrogens).
Adverse effects on materials
3.47 Contaminants in steam can have a damaging effect
on the materials of load items and the sterilizer.
3.48 Reactive contaminants in the steam can cause
corrosion or otherwise impair the longevity or
function of the product. Reactions can occur when
contaminants interact with the product directly, or
indirectly (by interacting with materials that will
subsequently come into contact with the product).
3.49 The steam also comes into direct contact with the
internal surfaces of the sterilizer pressure vessel and
associated equipment and instrumentation.
Contaminants within the steam can react with the
materials of construction and cause corrosion of the
equipment or otherwise impair its longevity or
function.
3.50 The reaction of steam with surfaces is affected by
its pH. In general, steam of a low pH (acidic) will
react with and dissolve metals. A pH of
approximately 7 (neutral) is ideal, and deviation
towards alkaline (for example to pH 8) is
acceptable.
3.51 Contaminants of concern include the following:
a. Alkaline earth metals cause hardness which
can lead to build-up of limescale on load items,
in the sterilizer chamber and in pipework. Most
problems are caused by calcium and
magnesium, and to a lesser extent strontium.
b. Iron, whether in metallic or ionic form, is
corrosive to stainless steel.
c. Chlorides in the presence of oxygen lead to
pitting corrosion and (to a lesser extent) crevice
corrosion in stainless steel. The effects can be
controlled by limiting the amount of oxygen in
the feedwater (see Figure 3).
d. Phosphates and silicates act to concentrate
chloride ions and so promote their corrosive
effects.
3.52 The materials used in the construction of load
items and of the sterilizer itself will determine
which contaminants are of greatest importance in
each case. BS EN 285, the European Standard for
sterilizers used to process medical devices, offers
24
guidance on materials of construction suitable for
all steam sterilizers.
3.53 Steam sampling systems should be constructed of
materials that will not react with, and hence
contaminate, the sample being collected.
Products vulnerable to steam-borne contamination
3.54 Any product can become contaminated if it comes
into contact with the steam supplied to sterilizers.
Contaminants in the steam are deposited on the
product as the steam condenses during the heating-
up stage. The amount of steam condensing, and
hence the amount of contamination deposited, is
proportional to the heat capacity of the load item,
which in turn is proportional to its mass and the
specific heat capacity of the material from which it
is made. A massive metal item will therefore receive
much more contamination than a light plastic item
of similar size and shape heated to the same
temperature.
3.55 The amount of contamination remaining at the
end of the cycle will depend on how much
condensate is retained at the surface of the product.
Where condensate can drain freely from
unwrapped items, a small fraction of the deposited
contaminants will be held in a thin film of water
and the total amount remaining when the film is
evaporated will be proportional to the exposed
surface area of the item. Where condensate is
trapped in cavities or held in the packaging close to
the surface, the amount of contamination retained
will be proportionally greater.
3.56 Packaging materials for steam processes have a
filtering effect that protects against contamination
to some extent. Particulate matter is normally
trapped on the outer wrapping (giving rise to
discoloured packs), but smaller particles and all
molecules will pass through with the steam and be
transferred to the product as the steam condenses
on it.
3.57 Whether such contamination has any adverse effect
depends upon the nature and intended use of the
product. Vulnerable products are:
a. those that would permit direct transfer of
contaminants to the patient, including:
(i) medicinal products;
(ii) porous goods such as dressings and swabs;
(iii) surgical instruments and utensils;
b. those that would permit indirect transfer of
contaminants to a patient, such as equipment
used in pharmaceutical manufacturing (see
paragraph 3.59, Sources of contamination);
c. those that would be impaired or inactivated by
the presence of one or more of the possible
contaminants, including:
(i) certain medicinal products;
(ii) laboratory products for in vitro diagnostic
use.
3.58 Various items of equipment used in the
manufacture of sterile pharmaceuticals and medical
devices should be sterilized before use. It is
important that during sterilization these items are
not tainted with contaminants that can be
transferred to the product being manufactured,
whether that product is terminally sterilized or
produced aseptically. Such items of equipment can
include mixing vessels, filling heads, sterilization
grade filters, filling lines, pipes and tubing for
material transfer, connectors, and so on.
Sources of contamination
3.59 Contaminants delivered to the sterilizer in steam
can arise from a number of sources:
a. contaminants present in the public water supply
from which the steam is generated;
b. contaminants arising from treatment of the
boiler feedwater;
c. contaminants arising in the distribution system
carrying steam to the sterilizer.
Public water supply
3.60 While the quality of mains water supplies differs
considerably from place to place, it can normally be
relied upon to meet the minimum standards set out
in the Water Supply (Water Quality) Regulations
2000 (as amended). These specify more than
50limits for a wide range of impurities including
dissolved minerals, organic compounds and
microorganisms.
3.61 There are no controls, however, on the amounts of
atmospheric gases dissolved in mains water, all of
which will be present in small and varying
amounts. Air is the principal non-condensable gas
that can impede steam sterilization, and carbon
dioxide and oxygen are important contributors to
corrosion in boiler systems.
3 Steam plant
25
3.62 Most water companies use chlorine as a means of
microbiological control. The disinfection effect of
the chlorine can be largely lost, however, by the
time the water reaches the point of use.
3.63 Water taken from the mains, and subsequently kept
in storage tanks before use, can have significantly
higher counts than the original mains water. In the
summer months counts as high as 105106 mL
1

are not uncommon. This may be of particular
concern for sterilization since some 98% of the
bacteria found in water supplies are reported to be
Gram-negative bacteria, which are the predominant
source of pyrogens. Further guidance may be found
in Health Technical Memorandum 04-01.
3.64 There are no requirements for suppliers to measure
or control the level of pyrogens in mains water.
Boiler feedwater treatment
3.65 Further contaminants can be introduced either
deliberately or inadvertently as a result of
treatments applied to mains water before it can be
used as boiler feedwater.
3.66 Base-exchange water softeners remove calcium and
magnesium ions from the water and replace them
with sodium ions (see paragraph 3.99, Steam from
a dedicated generator). Sodium levels will therefore
be raised in mains water softened by this method.
The use of brine to regenerate the ion-exchange
beds can temporarily raise the level of chloride.
3.67 Bacterial growth can occur in water softening,
deionisation or reverse osmosis plant unless the
manufacturers operating and maintenance
procedures are strictly adhered to.
3.68 While bacteria will not survive the steam
generating process, the pyrogens they produce
could be delivered to the sterilizer.
3.69 Any chemicals added to the boiler water can be
carried into the steam as contaminants either in
droplets of water entrained in the steam during the
evaporative process or as volatile components
present as gases. Filming amines and other
corrosion inhibitors and chemicals used to prevent
corrosion in steam systems and boilers should only
be used in concentrations that are proven not to
pose a risk to patients via surgical instruments and
medical devices they are in contact with, or not to
have an adverse effect on instruments or packaging.
Concentrations of such chemicals should be
carefully monitored to ensure that safe limits are
not exceeded.
Steam distribution system
3.70 Steam is chemically aggressive; the purer the steam
the more reactive it is. Reaction with pipework and
valves can lead to contamination of the steam with
corrosion products such as magnetite (Fe
3
O
4
).
Often in the form of fine particulates, these
products are not readily removed by the strainers
normally installed in steam services. Users of old
installations have occasionally noted black or
reddish-brown discoloration of packaging material
by particles of magnetite shed from the walls of the
steam pipes.
3.71 The hydrogen liberated by the formation of
magnetite (400 mL for each gram of iron) can
contribute appreciably to the amount of non-
condensable gases in the steam delivered to the
sterilizer, especially in new installations with long
pipe runs.
3.72 Contamination is also likely to arise at points where
water can collect, such as dead-legs, gauges and
poorly maintained traps. Trapped water can result
in rust, which can be shed into the steam as
particles, and bacterial growth, which can lead to
the formation of biofilms, which periodically
generate high levels of contamination as they
slough off.
3.73 Guidance on avoiding contamination from mains
steam distribution systems can be found in
paragraph 3.85, Steam from the mains steam
supply.
Steam quality requirements
3.74 The requirements in Table 5 should be met when
measuring the quality of steam.
Steam in practice
Introduction
3.75 This section discusses the principles by which
steam conforming to the steam specifications in
Table 5 might be generated. It offers practical
guidance on how to achieve steam standards for
sterilizers supplied by mains steam and sterilizers
supplied by a dedicated steam generator.
3.76 Full costings should be obtained when the relative
merits of different steam supplies are being assessed.
The cost of the testing required to demonstrate that
a mains steam system can consistently produce
steam might amount to a considerable fraction of
the capital cost of a dedicated steam generator.
26
Table 5 Specification for contaminants in condensate
collected according to the method described in
BS EN 285
Physical qualities:
Dryness 0.95
NCG 3.5%
Superheat 25C
Particulate
qualities:
Silicate 0.1 mg/L (corrosion)
Heavy metals 0.1 mg/L (corrosion and load)
Cadmium 0.005 mg/L (corrosion)
Lead 0.05 mg/L (corrosion)
Chloride 0.1 mg/L (corrosion), 0.5 mg/L
(load)
Phosphate 0.1 mg/L (corrosion and load)
Conductivity 3 S/cm (corrosion), 35 S/cm (load)
pH 57 (corrosion)
Hardness 0.02 mmol/L (corrosion)
Appearance clear, colourless, no sediment
(corrosion), clear and colourless (load)
Endotoxins 0.25 EU/mL (load)
Ammonium 0.2 mg/L (load)
Nitrate 0.2 mg/L (load)
Sulphate Ra (load)
Oxidisable Sub Ra (load)
Evap Residue 30 mg/L (load)
Calcium &
magnesium
Ra (load)
NOTE: This table is a combination of tables A1 (re:
corrosion) and A2 (re: load) in BS EN ISO 17665 and BS
EN 285. Compliance with this Table addresses the issues of
equipment corrosion and load contamination.
NOTE: Ra signifies methods and reagents specified in the
European Pharmacopoeia
How steam is made
3.77 At first sight it might be surprising that there
should be any contaminants in steam at all. Steam
is generated by boiling, in which liquid water is
converted into a gas. One might expect that any
impurities in the water would be left behind, as in
distillation, while pure steam in the form of H
2
O
molecules was delivered to the sterilizer.
3.78 Boiling occurs at a temperature where evaporated
water vapour has sufficient pressure to displace the
water immediately below the surface to form
bubbles of steam (at lower temperatures
evaporation occurs only from the surface). The
bursting of bubbles from the surface of the boiling
water is accompanied by the ejection of small
droplets of water. These droplets contain the same
dissolved and suspended solids that are present in
the water in the boiler. They are readily entrained
in the flow of steam and thus carry contaminants to
the sterilizer. Even if the water droplets
subsequently evaporate, the contaminants will still
be present in the form of solid particles.
3.79 Priming is a related phenomenon where significant
quantities of the boiler water can sporadically be
carried over into the steam. This is often as a result
of a sudden increase in the demand for steam,
which reduces the pressure above the water and
effectively lowers the boiling point, so increasing
the violence of bubbling. Having a level of water in
the boiler that is too high can also lead to priming.
Priming should be reduced by standard good
operating practice, such as running the boiler at or
near its maximum permissible pressure, using
pressure sustain valves where demand causes a
reduction in pressure in the distribution system and
not in the boiler.
3.80 High concentrations of impurities in the boiler
water also promote carry-over. They reduce the
surface tension and so increase the agitation of the
water surface. They can also cause the formation of
a stable foam above the water surface leading to
severe carry-over. Slugs of water are intermittently
discharged from the boiler along with the steam,
severely prejudicing the quality of the steam.
3.81 A crucial aspect of boiler design, therefore, is to
ensure the best possible separation and removal of
such entrained moisture.
Summary of requirements for steam
3.82 From the above considerations, the requirements
for generating steam can be summarised as follows:
a. feedwater should be as free as possible of
contaminants, especially those specified for
steam in Table 5;
b. the boiler should be designed to prevent water
droplets being carried over into the steam;
c. the boiler should be operated to prevent
foaming and priming;
d. the boiler and distribution system carrying
steam from the boiler to the sterilizer should be
resistant to corrosion.
3 Steam plant
27
3.83 A boiler system designed and operated to provide
minimal carry-over of entrained water droplets will
be able to maintain a low level of contaminants in
the steam even where the quality of feedwater is
poor.
3.84 Feedwater treatment might not be the decisive
factor in the ability of a system to deliver steam.
However, if the feedwater is of low quality, even
small deviations from optimum operating
conditions might result in large amounts of
contaminants being carried over and delivered to
the sterilizer. The designer of a robust steam supply
should ensure that all the above requirements are
met.
Steam from the mains steam supply
3.85 Experienced and monitored tests have shown that
steam can be obtained from well designed,
constructed and operated conventional boilers and
distribution systems of the type found in most
hospitals. If steam from this source is chosen, it is
essential to demonstrate compliance and identify
maintenance and boiler treatment regimes
necessary for reproducibility.
3.86 Where a central supply does not deliver steam of
acceptable standard, it is possible that the quality
might be sufficiently improved by changes in
operating practice and relatively minor engineering
modifications. However, it is unlikely to be
economical to embark on extensive remedial works
such as the introduction of new feedwater
treatment plant or the replacement of distribution
pipework. It might be more cost-effective to install
a dedicated steam generator solely to supply
sterilizers (see paragraph 3.99, Steam from a
dedicated generator).
Boiler design and operation
3.87 The first step in assessing whether steam can be
supplied from the mains is to examine the design
and operation of the boiler plant.
3.88 An important consideration is the proportion of
boiler feedwater that is fresh make-up water
rather than steam condensate returned from the
distribution system. In most large hospitals where
steam is supplied centrally, only a small fraction of
the steam demand is due to sterilizers (which
discharge most of their condensate to waste) and
therefore the bulk of the condensate is returned to
the boiler. This makes it more feasible to control
the level of contaminants in the boiler. While the
nature of the feedwater treatment is also of
importance, the requirements for steam are unlikely
to be achieved if the proportion of make-up
feedwater exceeds 15%.
3.89 The level of total dissolved solids (TDS) in the
boiler water is an important factor both in the
prevention of foaming (see How steam is made)
and for the contaminants that might be present in
the entrained water droplets. If steam is to be
produced, TDS levels should be below 2000 ppm.
While some control of TDS concentration can be
exercised by appropriate feedwater treatments, the
boiler usually has a blow-down facility to allow
accumulated sludge to be expelled from the bottom
of the vessel. The water level gauge and TDS sensor
element should also be blown down at regular
intervals.
3.90 Filming amines, which are often added to feedwater
to prevent corrosion of condensate return pipes, are
toxic and are not acceptable for boilers supplying
steam for sterilizers. If it is not possible for the
boiler to be operated without filming amines,
another source of steam should be found.
3.91 While the boiler is unlikely to have been designed
with the requirements of steam in mind, it should
nonetheless have some means of preventing water
being carried over into the steam. The chief
precaution against carry-over is good practice in
operating the boiler so that foaming and priming
do not occur (see paragraph 3.77, How steam is
made). Discussion with boiler-room staff will
ascertain the degree to which operating procedures
are successful in this regard.
3.92 Steam sampling points on the boiler are desirable
and should be installed if they are not already
fitted.
3.93 As the operational management of the steam supply
will normally be outside the Users control, the
User should consult with the AP(D) to ensure that
the boiler-room staff are aware of the principles of
saturated steam for sterilization and that the
necessary assurances will be met. The appointment
of suitably qualified and trained boiler-room staff is
an essential part of this process.
Distribution system
3.94 The distribution system also influences the quality
of steam delivered to the sterilizer. The design of
distribution systems suitable for the delivery of dry,
28
saturated steam is considered in paragraph 3.1,
Steam supply.
3.95 A purpose-built distribution system for steam
would normally be constructed of stainless steel.
However, when a large conventional installation
has been in use for a number of months, a hard
protective layer of oxide (magnetite) might have
formed on the inside of the steam pipes (see
paragraph 3.59, Sources of contamination).
Providing the steam condensate is neutral or
alkaline, this coat will remain intact and permit the
use of the pipework for the distribution of steam.
Acidic condensate in the presence of moist air,
however, can break down the layer, leading to
corrosion, which might then be shed as
contaminating particles.
3.96 It is important that the distribution system is free
of dead-legs and other places where condensate
might become trapped. During periods when the
steam supply is off, such accumulations might
become a focus of microbial growth. The trapped
water might then be swept up into the steam when
the supply is restored. Although the
microorganisms might be killed by the steam,
pyrogens will not be inactivated at the temperature
of the steam and might be delivered to the sterilizer.
3.97 Other key points for a distribution system suitable
for steam include:
a. correctly sized automatic air vents throughout
the pipework distribution system to minimise
the amount of air and other non-condensable
gases delivered to the sterilizer;
b. properly sized and selected steam traps to
remove condensate and air (if designed to do
so);
c. steam pipeline velocities kept below 25 m s
1
to
allow steam traps to remove entrained moisture
effectively and to prevent condensate being
drawn out of them;
d. steam separators near the steam take-off on
boiler plant prone to generating wet steam;
e. strainers to protect control valves, steam traps
etc.
Quality assurance
3.98 Where a mains steam supply is found to be capable
of meeting the steam specification, Users should
assess whether the steam quality can be maintained
under all operating conditions. There are several
points to consider:
a. Frequent testing of the steam at the sterilizer
will provide assurance that the steam
specification is consistently met.
b. Competing demands on the steam service from
other units in the hospital can degrade the
steam quality at the sterilizer.
c. Steam quality is apt to vary through the year as
the boiler room responds to changing seasonal
demands.
d. An otherwise effective steam supply can quickly
deteriorate if appropriate periodic maintenance
is not carried out.
e. Arrangements should be made for the User to
be warned of imminent engineering
modifications, maintenance and changes in
steam generation, distribution and operating
practice. If changes are likely to be made
without the Users knowledge, the supply
cannot be considered a reliable source of steam.
Steam from a dedicated generator
3.99 A dedicated steam generator, whether supplying
one or several sterilizers, should be used where
steam cannot be reliably obtained from the mains
supply or for new installations. Since the bulk of
the condensate from sterilizers is discharged to
waste and not returned to the boiler, such
generators might have to run on practically 100%
make-up feedwater.
3.100 A dedicated system should therefore:
a. minimise the amount of non-condensable gases
and other contaminants in the boiler feedwater;
b. prevent liquid water leaving the boiler and
being delivered in the steam;
c. prevent microbial growth in any storage tank or
pipework;
d. be constructed from materials resistant to
corrosion and particle shedding, such as low-
carbon stainless steel (type 316L).
3.101 The capacity of the generator should be sufficient
to meet both maximum and minimum demands
while still maintaining the requirements for
dryness and non-condensable gases specified in
paragraph 3.207, Non-condensable gas test.
3 Steam plant
29
3.102 Steam sampling points should be fitted between
dedicated generators and the sterilizer entry point
so that steam quality tests can be performed.
Moisture separation
3.103 A steam generator should allow the entrained
water droplets to be separated from the steam
before it is delivered to the sterilizer. The baffles
used in some conventional boilers are not normally
adequate for this purpose, but good results have
been obtained on experimental machines using
cyclonic separators, which essentially spin-dry the
steam by causing it to rotate at high speeds.
Experience has shown that the fitment of a large
plate type separator fitted in the main steam line
can safely remove water carry-over from the
distribution system prior to the header. This will
protect the loads as processed in the porous-load
sterilizers.
3.104 The manufacturer will have measured the
efficiency of moisture removal by spiking the
feedwater with high levels of endotoxin (at least
10
3
EU mL
1
) and testing samples of the steam
for endotoxin levels by means of the LAL test (see
paragraph 3.263, Pyrogens). This work should be
undertaken only by personnel with appropriate
training and experience. Tests on an experimental
steam generator have shown that reduction factors
greater than 105 can be consistently achieved.
3.105 Adequate moisture removal should be maintained
over the entire range of steam demand, typically
up to 200 kg h
1
for each sterilizer.
Heating
3.106 A single 600 L porous-load sterilizer requires a
steam generator capable of converting energy at a
rate of up to 50 kW. A group of sterilizers will
require a proportionately higher heating power.
3.107 Where existing sterilizers are supplied from a
central boiler, the ideal solution is to install a
generator heated by mains steam. The steam
generator is then effectively a steam-to-steam
calorifier, in which the mains steam is used only to
heat the feedwater and does not come into contact
with the steam for the sterilizer. Primary steam
requirements for this type of calorifier will
normally be 300 kg h
1
for each sterilizer at a
minimum pressure of 10 bar and operating on
100% condensate return. Where mains steam is
not available, a small packaged boiler might be a
convenient source of steam for heating, but should
not itself be regarded as a source of steam.
3.108 Generators might be heated by electricity, but size
for size, an electrically heated generator cannot
match a steam-to-steam generator for heating
power. The pressure in the boiler cannot be
maintained at a high enough level to ensure
adequate removal of droplets by the cyclonic
method described above. Gas-fired heating is not
recommended for stainless steel boilers.
Materials
3.109 The boiler and other parts of the generator that
come into contact with feedwater or steam should
be constructed of corrosion-resistant stainless steel
(such as low-carbon 316L grade).
3.110 Pipework connecting the steam generator to the
sterilizer should be also constructed in stainless
steel. Since the generator can be sited close to the
sterilizer, it is a false economy to re-use existing
sections of the steam supply system.
3.111 While existing sterilizers should not be harmed by
a carefully-designed steam system, steam-contact
surfaces of iron, mild steel or copper should be
avoided in new machines. In most cases this will
require contact surfaces to be fabricated in stainless
steel as specified in BS EN 285.
Feedwater treatment
3.112 Since there is no return of chamber condensate
from the sterilizer, the quality of feedwater is
crucial to the performance of a steam generator. It
is especially critical for those generators that
operate on a straight-through principle and have
no reservoir of water within the boiler.
3.113 Water drawn from the public supply might be
hard, that is, containing significant concentrations
of the salts of the alkaline earth metals (chiefly
calcium and magnesium), and might also have
traces of other contaminants that need to be
removed. To assess the need for water treatment,
Users should obtain an analysis of the mains water
from the supply company providing a trend over a
12-month period. Under the Water Supply (Water
Quality) Regulations 2000 (as amended) such an
analysis should be supplied to customers on
request and free of charge.
3.114 Although the stated water quality can be relied on
most of the time, gross contamination of water
30
supplies might occasionally occur due to
engineering works and treatment failures.
3.115 Full water treatment consists of three stages:
a. softening (to remove scale-forming
contaminants that might harm the boiler);
b. purification (to remove other undesirable
contaminants);
c. degassing (to remove corrosive and non-
condensable gases).
3.116 The need for softening treatment will depend on
the hardness of the local water supply. Where the
water is soft it might be possible to achieve the
steam requirements without further treatment. In
such cases, users should be aware that the quality
of the steam will vary with the quality of the water
supply, and that the quality of the steam should be
frequently monitored to ensure that the steam
specification is maintained.
3.117 In hard-water areas a base-exchange softening
plant will normally be required. In this process
calcium and magnesium ions are exchanged for
sodium ions in a zeolite column (permutite
process). The columns are periodically regenerated
by flushing with brine (sodium chloride). The
flushing should be carried out in accordance with
the manufacturers instructions to prevent chloride
ions being introduced into the softened water.
3.118 Microbial growth might occur in the columns
unless the equipment is correctly operated and
scrupulously maintained.
3.119 Steam generators that are highly efficient at
removing water droplets might be able to attain
steam standards without the need for further
purification of the feedwater, but this can only be
determined by experiment. Until steam technology
has been further developed and proven, Users
should consider installing feedwater purification
plant.
3.120 Purification might be achieved by either reverse
osmosis or deionisation. In reverse osmosis (RO),
water is forced through a semi-permeable
membrane, which filters out contaminants to a
high degree of efficiency. In deionisation (DI), ions
and charged particles are removed either by electric
fields or by ion exchange in resin beds. Although
RO cannot normally attain the degree of purity
possible with DI methods, it is more than
adequate for feedwater intended for purpose-built
steam generators. Moreover:
a. RO is cheaper to install and to run than DI;
b. RO removes particulate matter, organic
molecules and pyrogens that DI cannot;
c. RO water is less corrosive to steel and copper
than DI water;
d. maintenance requirements are less demanding
than for DI units.
3.121 When seeking quotations for the supply of water
purification plant, the User should ensure that the
manufacturer is aware of the intended use of the
purified water, and should establish that it will not
be corrosive to the materials of the steam
generator.
3.122 Further treatment of the feedwater to remove
dissolved gases should be carried out. This is
usually achieved by pre-heating the water in a hot
well maintained at temperatures of 8090C (at
atmospheric pressure) to drive dissolved gases out
of solution. The hot well is often provided by the
manufacturer of the steam generator as an integral
part of the unit.
3.123 A schematic illustration of a complete water
treatment system is shown in Figure 3.
Testing for compliance
3.124 This section discusses the testing regimes necessary
for the initial validation of a steam supply for
sterilization and for subsequent periodic testing.
Methods for taking steam samples are given in this
section and their analysis is discussed in paragraph
3.195, Analysis of samples. Further information
on steam, steam generators and their management
can be found in this chapter.
Where to take samples
3.125 To ensure a thorough quality assessment of the
steam supply, water and steam samples should
Mains water
Base exchange
softener
Reverse osmosis
purifier
Hot
well
Steam
generator
Sterilizer
Figure 3 Typical feedwater treatment for a steam generator
3 Steam plant
31
ideally be taken throughout the steam generating
and distribution system from incoming water to
steam at the sterilizer, though such extensive
sampling will rarely be needed in practice.
Examples of points at which samples may be taken
include:
a. mains water, which after suitable treatment will
be used as feedwater to the boiler;
b. treated water, which may include one or more
distinct treatment stages. Samples should be
taken from the inlet and outlet pipes as close as
possible to the treatment plant. To monitor the
various stages of water treatment, samples
should be taken after each stage;
c. feedwater, the water admitted to the boiler
from the hot well, without any dosing
treatments admitted simultaneously or
separately to the boiler;
d. boiler water, the water in the boiler prior to
blow-down;
e. boiler steam, the steam leaving the boiler;
f. steam for use in the sterilizer, the steam
delivered to the sterilizer, sampled at the steam
service pipe.
3.126 Testing of the total system can be costly and may
only be required where major problems are
experienced.
3.127 The sampling points should be chosen so that the
samples obtained will allow the identification and
quantification of any significant changes in
contamination levels at each stage in the process.
For example, sampling before and after a base-
exchange water softener may reveal an increase in
bacterial endotoxin levels from a contaminated ion
exchange column. A full set of sampling points at
strategic locations will allow such problems to be
investigated with a minimum of disruption, even
though most of them will rarely be used in routine
operation. Guidance on the design and use of
sampling points is given in paragraph 3.159,
Sampling points.
3.128 The design and construction of the system will
determine how many sampling points would be of
value. For a mains system supplying a large
hospital, all the above points may be desirable. For
a sterilizer with an adjacent, dedicated steam
generator supplied from a simple treatment plant,
fewer would be needed.
Validation and periodic testing
3.129 Validation tests should normally be carried out on
the following occasions:
a. on initial validation of the steam-raising and
distribution plant;
b. on initial validation of the sterilizers served by
the steam plant;
c. on yearly testing or revalidation of the
sterilizers;
d. when there is operational evidence that the
steam quality may have deteriorated;
e. after any significant modification of the steam
plant or its operation.
3.130 Periodic tests should be carried out during
quarterly testing of the sterilizers.
3.131 As a minimum, samples for validation should
include the feedwater and the steam for use in the
sterilizer. Testing the steam without testing the
water from which it is raised can lead to a false
sense of security. For example, high levels of
pyrogens in the feedwater will not necessarily
produce contamination in the steam when the
boiler is operating under loads that do not induce
carry-over or priming. But during normal
operation this could occur, and contamination in
the feedwater would require urgent investigation
and remedial action.
3.132 Once a steam supply has been validated, periodic
testing of steam quality will be necessary.
Quarterly testing of electrical conductivity is
recommended (see paragraph 3.296, Field test for
pH and electrical conductivity), but the frequency
will depend upon the particular application and
the consistency of control established from
historical data. Other tests might be necessary if
one or more of the possible contaminants is critical
for the process or product.
Mains steam supply
3.133 Formal validation should be carried out once the
user is satisfied that the chosen system is capable of
supplying steam and boiler-operating procedures
have been established. Much exploratory testing
may be required before this point is reached.
Validation test
3.134 The CP(D) should consult boiler room records to
establish how the demand on the boiler varies
32
through a typical working day (in a large hospital
sterilizers are likely to contribute only a small
fraction of this load). The object is to ensure that
times of highest and lowest demand can be reliably
identified so that representative steam samples can
be taken.
3.135 It may take several minutes for steam produced in
the boiler to arrive at the sterilizer, due to the large
amount of steam contained within a mains
distribution system. This means that the steam
quality at the sterilizer might not be representative
of the quality at the boiler. In particular, the steam
in the pipes may have been generated at a time of
less extreme demand and therefore be of higher
quality, although if it has been standing in the
pipes it is more likely to have been contaminated
by the distribution system. CP(D)s should
therefore ensure that the steam sample was
generated when the boiler was operating at the
appropriate level of demand, for example by
flushing the plant room manifold pipework with
fresh steam immediately before samples are taken.
In practice, the samples should be satisfactory if
the boiler demand has been steady for several
minutes and remains steady while the flushing
takes place and the samples are taken.
3.136 Two samples each of feedwater and steam at the
sterilizer should be taken:
a. at a time of highest demand;
b. at a time of lowest demand.
3.137 Samples should consist of:
a. a full set of duplicate samples for laboratory
analysis as described in paragraph 3.175,
Sampling for laboratory analysis;
b. a field sample as described in paragraph 3.164,
Sampling for field analysis.
3.138 Where more than one sterilizer is supplied from
the same steam manifold, steam samples should be
taken at the sterilizer furthest downstream from
the boiler. It is not necessary to sample the steam
at each sterilizer.
3.139 Samples should be given a full laboratory analysis
(see paragraph 3.175, Sampling for laboratory
analysis). The field sample should be tested for
electrical conductivity on site as described in
paragraph 3.296, Field test for pH and electrical
conductivity.
3.140 If the steam samples fail the test, the feedwater
analysis should be examined to determine whether
the failure could be remedied by a simple
adjustment of the treatment regime. If not, further
samples may need to be taken at points other than
those mentioned in paragraph 3.125, Where to
take samples to establish where the problem
originates.
3.141 When validation has been completed successfully,
the mains supply may be used as a source of steam
for sterilization, although users should proceed
with caution until sufficient experience has been
gained to build confidence in the system. During
the first year of steam operation, the validation
tests should be repeated at intervals chosen to
coincide with the peak variations in seasonal
demand. This will provide further assurance that
the system is capable of meeting the steam
specification under all normal operating
conditions. If any tests fail during this period,
corrective action should be taken and the tests
repeated.
Periodic tests
3.142 Periodic testing of the steam supply should be
carried out on an annual basis to coincide with the
tests scheduled for the sterilizer. Periodic testing of
the feedwater is not necessary. The test should
consist of a conductivity measurement of a field
sample (see paragraph 3.296, Field test for pH
and electrical conductivity), and the conductivity
value should remain below the limit established
during validation. Failure of the periodic test
requires further investigation, normally by a full
laboratory analysis of both feedwater and steam.
3.143 Additional tests may be required if problems are
experienced with steam quality/ contaminants.
The advice of the AE(D) should be sought as to
frequency of testing required in that case.
Dedicated steam generator
3.144 A dedicated steam generator supplying one or
more sterilizers may not suffer competing demands
from other equipment and may be more likely to
be within the Users control. Consistency of steam
quality may therefore be demonstrated more
readily than for a mains steam supply.
3 Steam plant
33
Validation test
3.145 Validation can normally be carried out as soon as
the Contractor has installed the equipment and
completed their own installation tests.
3.146 The CP(D) should first establish when the steam
generator will be subject to the highest and lowest
demand. Depending on the design of the steam
plant, it is possible for either to constitute the
worst-case conditions for carry-over of moisture.
For example, a large plant designed to supply
several sterilizers and relying on a cyclonic
separator for removal of entrained water droplets
may be inefficient at the lower velocities generated
by a single sterilizer on light load.
3.147 The highest demand on the boiler usually occurs
when all sterilizers are operating simultaneously.
However, the period of peak demand (steam
admission into the chamber) is brief, and it is
difficult to synchronise the operating cycles so that
the peaks coincide for long enough to allow a
sample to be taken.
3.148 An alternative method is to vent steam from the
relief valve on the plantroom manifold. Users
should first ensure that the steam will be
discharged to a safe position outside the building.
The relief valve is designed to limit pressure in the
system and therefore this action creates a demand
on the boiler that is greater than the maximum
demand of the sterilizers. If steam samples
collected under these conditions comply with
steam specification, it can be assumed that the
generator will cope with the demand of the
sterilizers. If not, the generator may still comply if
loaded normally, and further testing will be
required.
3.149 A third possibility is to install a discharge valve on
the steam manifold designed to simulate the peak
demand of all sterilizers operating at the same
time.
3.150 The amount of steam contained within the
distribution system will be small, the steam
produced in the boiler will arrive at the sterilizer
almost instantly, and the steam sample collected
can be assumed to be representative of that created
in the boiler.
3.151 Two samples each of both feedwater and steam at
the sterilizer should be taken under conditions of
highest demand.
3.152 Samples should consist of:
a. a full set of duplicate samples for laboratory
analysis as described in paragraph 3.175,
Sampling for laboratory analysis;
b. a field sample as described in paragraph 3.164,
Sampling for field analysis.
3.153 Where more than one sterilizer is supplied from
the same steam generator, steam samples should be
taken at the sterilizer furthest downstream. It is not
necessary to sample the steam at each sterilizer.
3.154 Samples should be given a full laboratory analysis
(see paragraph 3.195, Analysis of samples). The
field sample should be tested for electrical
conductivity on site as described in paragraph
3.296, Field test for pH and electrical
conductivity.
Periodic tests
3.155 Periodic testing of the steam supply should be
carried out on an annual basis to coincide with the
tests scheduled for the sterilizer. Periodic testing of
the feedwater is not necessary. The test should
consist of a conductivity measurement of a field
sample (see paragraph 3.296, Field test for pH
and electrical conductivity under Tests for steam)
and the conductivity value should remain below
the limit established during validation. Failure of
the periodic test requires further investigation,
normally by a full laboratory analysis of both
feedwater and steam. Additional tests may be
required if problems are experienced with steam
quality/contaminants. The advice of the AE(D)
should be sought as to frequency of testing
required in that case. Failure of the periodic test
requires further investigation, normally followed
by a full laboratory analysis of both feedwater and
steam.
3.156 Revalidation should be carried out once a year, to
coincide with the yearly testing of the sterilizer.
Sampling
3.157 This section discusses methods for taking water
and steam samples for both field and laboratory
analysis.
3.158 There are two types of water and steam samples
that should be taken: field and laboratory samples.
Field samples will normally be taken and analysed
by the CP(D) in the course of testing the sterilizer.
Laboratory samples may be taken either by
personnel from the receiving laboratory or by the
CP(D) (if qualified).
34
Sampling points
3.159 Sampling is required in each part of the system
where the composition of the water or steam
might need to be confirmed, or where changes in
composition might need to be determined.
Sampling points should be designed and
constructed to ensure that:
a. the sample taken is as nearly as possible
representative of the water or steam in that
section of the system;
b. the sample can be taken without contaminating
it;
c. the sample can be taken safely.
3.160 When possible, samples should be taken from
flowing rather than static parts of the system. For
example, in sampling a tank the samples are best
taken from the inflow or outflow pipes rather than
the static reservoir.
3.161 Where boiler water is to be sampled, the position
of the sampling point should be chosen with care,
giving consideration to the fact that the
composition of water can vary considerably at
different locations in the boiler. For boilers with
forced circulation the sampling point is best
located on the discharge side of the pump.
3.162 It is good practice to install coolers to ensure that
representative boiler water samples can be taken
safely.
3.163 Guidance on the design and construction of
sampling points is given in BS 6068-6.7, ISO
5667-7.
Sampling for field analysis
3.164 This method is suitable for taking steam and water
samples to be tested for electrical conductivity
during periodic tests. It should not be used for
samples intended for laboratory analysis.
Apparatus
3.165 Figure 4 shows the apparatus connected to a pitot
tube identical to the one specified for the steam
quality tests in Physical steam quality tests. The
pitot is fitted to the steam supply pipe near the
sterilizer. This standard pitot is not suitable for
laboratory samples. Figure 5 shows an alternative
pitot that may be used for all steam testing. If this
pitot is used for field samples or the tests in
paragraph 3.203, Physical steam quality tests, the
ball valve, nipple and socket should be removed.
3.166 Steam is led through a length of polypropylene
tubing and condensed as it passes through a bath
of cold or iced water.
3.167 This apparatus is suitable for use for samples that
are to be analysed immediately, such as for periodic
tests for electrical conductivity. It is not suitable for
samples intended for more sensitive analysis in the
laboratory. It is also unsuitable for taking samples
for pyrogen testing.
3.168 Steam pipework and sampling apparatus will be
hot and adequate precautions should be taken
against getting burnt. Thermal gloves and safety
glasses should be worn.
Method
3.169 Use new polypropylene tubes for each test or series
of tests. Clean the polypropylene sample bottle by
rinsing well with distilled water. Detergents should
not be used. Leave them to dry.
3.170 If the pitot is not already fitted, isolate the steam
supply and vent the pipe of pressure. Fit the pitot
tube into the pipe and secure the polypropylene
tube to it with a clip.
3.171 Restore the steam supply and allow steam to vent
through the polypropylene tube for at least 5 min
to restore the steam service to its stable operating
temperature. Ensure that the condensate drains
freely. Close the steam valve.
3.172 Coil part of the tube into a sufficient number of
coils to ensure condensation of steam, place it in
the 8 L container and retain it in place. Fill the
container with enough cold water (add ice if
required) to immerse the coils.
3.173 Open the steam valve. The steam will condense in
the coils and condensate will emerge from the end
of the tube. Allow the first 50 mL of condensate to
discharge to waste and then collect approximately
250 mL in the sample bottle.
3.174 Seal and label the bottle. The electrical
conductivity should be measured promptly as
described in paragraph 3.296, Field test for pH
and electrical conductivity.
Sampling for laboratory analysis
3.175 This method is suitable for taking all required
samples, including those to be subjected to full
laboratory analysis and the test for pyrogens.
3 Steam plant
35
Pitot tube (see Figure 10) remove the nipple
and ball valve assembly before inserting
the polypropylene tube
Connect polypropylene tube to
the pitot tube and secure
e.g. by a jubilee clip
Polypropylene tube of bone 6 1 mm
To sterilizer
Steam
Coil of the tubing to be
restrained in the water
by a clamp or a
suitable weight
8-litre container
filled with water
250 ml polypropylene
sample bottle
Note: This method is only suitable for taking samples intended to be tested on site. It is not suitable
for samples taken for bacterial endotoxin tests.
Steam supply
The pitot tube to be located as described
in Figure 10
150 2
Silver solder
25 2
2 0,1
G
1
/4
+
0
-
0
,
6
6
Diameter in mm may be calculated from
the following (but see also Figure 10):
(1/p)
2
to 1 decimal place
5 p
2
where p is the maximum supply
pressure in bar
e.g. for 4 bar
Diameter = 10 (1/4)
2
= 0.6 mm
Pitot tube
To sterilizer
Nipple and ball valve assembly
Pitot tube
Ball valve
Bush
Socket Nipple
Threaded
connector
Stainless steel
tubing
Note: All parts to be constructed from either
low carbon stainless steel or stabilised
stainless steel, complying with at least
316 quality.
Figure 4 Steam sampling system for field analysis
Figure 5 Typical pitot sampling tube assembly
36
Apparatus
3.176 The apparatus is shown in Figure 6. All
components, including the condenser and valves,
are constructed in 316L stainless steel. The tubing
is made in short sections connected by
compression joints to form the required length and
configuration. The sections are short enough to
allow each element to be thoroughly cleaned,
sterilized and depyrogenated before use.
3.177 The standard pitot used with the field sampling
apparatus described above is not designed to take
compression fittings and so cannot be used with
this apparatus. It should be replaced with the
modified pitot and ball valve shown in Figure 6.
3.178 The apparatus is suitable for taking samples for all
the determinands of interest. It may be used for
steam condensate or water samples throughout the
steam-raising system. In theory there is a risk of
some contamination of the sample from metals
that could be extracted from the stainless steel, but
the grade of steel chosen is no more reactive than
those used in the construction of steam pipes and
equipment. If, for whatever reason, the steam
reacts with the sampling apparatus, it will also have
reacted with the installed system.
Method
3.179 Clean and prepare sample bottles and stainless
steel components according to the instructions
from the receiving laboratory. Normally, two sets
will be used for steam samples and one for control
samples. Ensure that the bottles are labelled as
described in paragraph 3.182, Handling of
samples for laboratory analysis.
3.180 Open the valve on the pitot and allow steam to
vent through the cooler for at least 5 min before
turning on the cooling water. The steam will
condense in the coil and condensate will emerge
from the end of the tube. Allow the first 50 mL of
condensate to discharge to waste and then collect
samples in the first two sets of bottles.
3.181 Fill the third set of bottles with Water for Injection
BP and preserve and analyse this in the same
manner as the two sets of steam samples.
Note
These negative control samples provide evidence that
the choice of container, cleaning system and
preservative is appropriate.
Handling of samples for laboratory analysis
3.182 It is important that the physical, chemical and
biological properties of water and steam samples
remain stable from when they are sampled until
they arrive at the laboratory for analysis. The
conditions in which the sample should be kept are
determined by the contaminants for which the
water is to be tested. The material of the sample
container is also important since it may interact
with substances in the water; plastic is suitable for
some parameters, glass for others. See Figure 6.
3.183 General guidance on these points is given below;
more specific advice is in BS EN ISO 5667-3, BS
6068-6.3. The laboratory carrying out the analysis
will normally provide all the necessary containers,
preservatives and labels with full instructions for
their use.
Containers
3.184 There is no single material suitable for containing
samples with all relevant contaminants. Containers
may be made from polyethylene, polystyrene,
polypropylene, glass or borosilicate glass. The
receiving laboratory will normally supply the
appropriate containers, with full instructions for
their use.
3.185 Each type of container requires a different cleaning
procedure to ensure samples are not contaminated
by residues. The instructions from the receiving
laboratory should be followed.
3.186 The laboratorys instructions on filling and closing
the bottles should be followed. Most bottles should
be filled to the brim and then stoppered or capped
to ensure that as little air as possible remains above
the sample. A small air space should be left above
samples to be frozen.
Sample preservation
3.187 The purpose of preservation is to maintain the
concentration and state of the contaminant of
interest unchanged, from when the sample was
taken to arrival in the laboratory.
3.188 There are many possible interactions that would
adversely affect the sample. The contaminant of
interest might:
a. polymerise or, if already a polymer,
depolymerise;
b. react with other constituents of the sample;
c. react with atmospheric oxygen or carbon
dioxide becoming dissolved in the sample;
3 Steam plant
37
d. be consumed, modified or be produced in
higher concentrations by microorganisms
growing in the sample;
e. react with, or be adsorbed or absorbed by, the
material of which the container is constructed.
3.189 The sample and the extent and nature of any
contaminants present, will determine which
reactions and changes may occur. The more
contaminated a sample, the more likely it is that
changes will occur. In addition, the temperature
during transport and storage, exposure to light, the
container material and any special precautions
used in its preparation, and the elapsed time before
analysis, will all affect reactions and changes.
3.190 While it is desirable for all samples to be cooled
(normally at 25C), some will require the
addition of an acid preservative and others will
need to be frozen. The receiving laboratory will
specify the preservative treatment for each
container and supply suitable reagents where
necessary.
3.191 Few preservative treatments for the contaminants
specified for steam are valid for more than
24hours and some for a much shorter time.
Prompt despatch and analysis are therefore
essential.
Coil approx. 50 mm diameter
with total tube length of
>

1.5 m
Pitot tube Isolating valves
6 mm O/D tubing. This should
be in short lengths
connected by straight screwed
compression fittings
To waste
Condenser
(may be replaced with cooling
coil in open cold water trough
with continuous flow maintained
by a constant level device)
(water flow adjusted so
that temperature of discharged
condensate < 50C)
Discharge point
Cold
water
Note: The sampling circuit should be constructed from either low carbon stainless steel or
stabilised stainless steel, complying with at least 316 quality.
T T
T
Figure 6 Steam sampling system for laboratory analysis
38
Identification of samples
3.192 Each container should be unambiguously labelled
with a water-resistant label at the time of sampling.
The laboratory will supply suitable labels and
instructions. The information to be recorded
should include:
a. the establishment at which the sample was
taken;
b. the date and time at which the sample was
taken;
c. the name of the person taking the sample;
d. clear identification of hazardous materials
present (for example acids used as a
preservative); and either:
e. an unambiguous reference number for
contemporaneous notes of the information in
(fk); or
f. the sampling point;
g. the nature of the sample (for example
condensed steam);
h. the determinand(s) for which the sample is to
be analysed;
j. any preservative treatment;
k. notes on any observations pertinent to the
analysis, such as an event not in accordance
with the sampling procedure that might affect
the analysis.
Packaging and transport
3.193 The samples should be packaged securely in
containers providing suitable protection from
breakage or external contamination during
transport. The containers should be kept as cool as
possible during transport. For transporting small
quantities of samples, domestic cool boxes provide
suitable protection and cooling.
3.194 The transport container should be accompanied
by a list of the samples being sent. A duplicate of
this list should be retained by the AP(D) and/or
User. The list should be sufficiently comprehensive
to allow confirmation of the identity of each
sample in the consignment.
Analysis of samples
3.195 This section discusses the means by which a
sample of steam condensate may be analysed for
compliance with the steam specification. The tests
are equally suitable for testing samples of steam or
water from elsewhere in the steam supply system,
provided the limitations of the pharmacopoeial
tests are understood.
Testing of samples
3.196 To determine whether a steam sample conforms
with the steam specification, it is necessary to carry
out tests for all the determinands listed in BS EN
285.
3.197 Laboratories invited to carry out these tests should
be accredited to a recognised standard.
Reporting of results
3.198 The report obtained from the laboratory for each
test should contain the following information:
a. the exact identity of the water sample;
b. the date and time the sample was received;
c. the date and time at which the test was
commenced;
d. the storage conditions if (b) and (c) are not the
same;
e. the determinand for which the sample was
analysed;
f. for non-quantitative tests, a statement as to
whether the result complies with specification;
g. for quantitative tests:
(i) the numerical value expressed in the unit
specified for each of the duplicate
determinations;
(ii) the mean of the results of the duplicate
determinations and the uncertainty that
might be associated with the final result;
h. a description of any pre-treatment of the
sample;
j. a description of the method used, including
reference to specific items of equipment,
calibration standards etc;
k. any deviations from the method or other facts
that might reasonably be expected to influence
the result obtained. These should be signed
both by the analyst responsible for carrying out
the determinations and the analyst or quality
controller responsible for checking the report.
3.199 For any given determinand there will usually be
several methods that are suitable and cover the
3 Steam plant
39
range of concentrations of interest. The choice of
method should be determined by factors including
availability of equipment, previous experience with
the method, cost, and sensitivity to interfering
substances that might be present. Consideration
should be given to:
a. the limit of detection, which should be lower
than the specified limit for the contaminant;
b. the accuracy of the method, which is of
particular importance in observing changes in
quality;
c. the likely presence of interfering substances in
the samples to be tested.
Comments on the tests
3.200 There are several ways in which numerical results
from any given analysis may be presented. The
user should specify that the results are quoted in
the units used in the clean-steam specification in
BS EN 285 so that the sample can readily be
compared with the specification.
3.201 The following sections give background
information on interpreting the results of some of
the steam tests and explain the relationships
between them.
3.202 The requirements for steam are stated in Table 5.
Physical steam quality tests
3.203 A continuous supply of saturated steam is required
for steam sterilization. Too high a level of non-
condensable gases will prevent the attainment of
sterilizing conditions; too little moisture carried in
suspension can allow the steam to become
superheated during expansion into the chamber,
while excess moisture can cause damp loads.
3.204 For all physical steam quality tests, the steam
should be sampled from the steam service pipe to
each sterilizer. The measurements are taken during
a period of maximum steam demand, when steam
is first admitted to the sterilizer chamber.
3.205 Silicone rubber tubing is porous to steam and
should not be used to carry steam in these tests.
3.206 Steam pipework and sampling apparatus will be
hot, and adequate precautions should be taken
against getting burnt. Thermal gloves and safety
glasses should be worn.
Non-condensable gas test
3.207 This test is used to demonstrate that the level of
non-condensable gases in the steam will not
prevent the attainment of sterilization conditions
in any part of the load. Possible sources of non-
condensable gases are discussed in paragraph 3.29,
Non-condensable gases. The method described
should not be regarded as measuring the exact level
of non-condensable gas, but as a method by which
the provision of acceptable steam quality can be
demonstrated.
Apparatus
3.208 The apparatus is shown and described in Figure 7.
All sizes are nominal. Alternative commercially-
available versions of this may be used. Robust
apparatus should lead to consistent result-
gathering. When using commercially-available test
units, correlation between the standard method
and the alternative method should be established.
For example, it may be necessary to ensure that the
temperature in the container remains above 65C
during the test in order to avoid dissolution of
carbon dioxide. The flow rate may also need to be
adjusted to ensure that 200 mL of condensate is
collected over the whole of the air-removal stage.
Method
3.209 Connect the needle valve to the steam service pipe
as shown in Figure 7. When performing this test
the pitot tube used for the superheat and dryness
tests should not be connected.
3.210 Assemble the apparatus so that condensate will
drain freely from the long rubber tube into the
sampling pipe. Copper or stainless steel tubing
may also be used.
3.211 Fill the container with degassed cold water,
preferably condensate, until it overflows. Fill the
burette and funnel with cold water, invert them
and place them in the container. Draw out any air
that has collected in the burette.
3.212 With the steam sampling pipe out of the container,
open the needle valve and allow steam to purge the
air from the pipe. Place the pipe in the container,
locate the end within the funnel, and add more
cold water until it flows through the overflow pipe.
3.213 Place the empty measuring cylinder under the
container overflow.
3.214 Adjust the needle valve to allow a continuous
sample of steam into the funnel sufficient to cause
40
a small amount of steam hammer to be heard.
Ensure that all the steam is discharged into the
funnel and does not bubble out into the container.
Record the setting of the needle valve. Close the
valve.
3.215 Draw out any air present in the burette; ensure
that the container is topped up with cold water
and that the measuring cylinder is empty.
3.216 Ensure that the sterilizer chamber is empty except
for the usual chamber furniture. Select and start
the operating cycle.
3.217 When the steam supply to the chamber first opens,
open the needle valve to the previously recorded
setting, allowing a continuous sample of steam
into the funnel sufficient to cause a small amount
of steam hammer to be heard.
3.218 Allow the steam sample to condense in the funnel.
Any non-condensable gases will rise to the top of
the burette. Overspill formed by the condensate
and the water displaced by the gases will collect in
the measuring cylinder.
From steam service
Tube must be
self-draining
To sterilizer
i
a
c
j
b
d
h
g
k
e
To trap set
f
a 50 ml burette with a minor mark of 1 ml
b parallel-sided funnel with a nominal opening of 50 mm
c rubber tubing size to suit funnel and burette
d 2000 ml container with overflow at 1500 ml
e steam sample delivery pipe 6 mm O/D with 75 mm upturn
f
1
/4 BSP needle valve
g 250 ml measuring cylinder with a minor mark of 10 ml
h burette stand
i rubber tubing
j thermometer 0100C with a minor mark of 1C
k overflow pipe
Figure 7 Apparatus for non-condensable gas test
3 Steam plant
41
3.219 When the temperature of the water in the
container reaches 7075C, close the needle valve.
Record the volume of gas collected in the burette
(V
b
) and the volume of water collected in the
measuring cylinder (V
c
).
3.220 Calculate the fraction of non-condensable gases as
a percentage as follows:
Fraction of non-condensable gases = 100 (V
b
/V
c
)
Results
3.221 The test should be considered satisfactory if the
fraction of non-condensable gases does not exceed
3.5%.
3.222 The test should be carried out twice further to
check consistency. If the results of the three tests
differ significantly, the cause should be investigated
before proceeding further.
Steam superheat test
3.223 This test is used to demonstrate that the amount
of moisture in suspension with steam from the
service supply is sufficient to prevent the steam
from becoming superheated during expansion into
the chamber. The test assumes that the steam
supply pressure is nominally 4.0 bar gauge. If the
supply pressure differs from this it might be
necessary to amend the acceptance criteria
accordingly.
3.224 The method described here uses a low-volume
sample, continuously taken from the centre of the
steam service pipe. The level of superheat
determined by this method cannot be regarded as
indicative of the true condition of the steam in the
pipe, since condensate flowing along the inner
surface is not collected. However, devices designed
to separate free condensate are incorporated into
the steam delivery system to the chamber, and
therefore the level determined by this method is
representative of steam conditions likely to prevail
within the chamber during the plateau period.
3.225 This test should normally follow a satisfactory test
for non-condensable gases.
Apparatus
3.226 A pitot tube is shown in Figure 8. The rest of the
apparatus is shown and described in Figure 9.
Method
3.227 Fit the pitot tube concentrically within the steam
service pipe as shown in Figure 8.
3.228 Fit the sensor entry gland to the steam service
pipe. Insert one of the sensors through the gland
and position it on the axis of the pipe.
3.229 Insert the second sensor through the gland in the
expansion tube and position it on the axis of the
pipe. Wrap lagging around the expansion tube.
Push the tube onto the pitot.
3.231 From the measured temperatures, record the
temperature in the steam service pipe (for use in
the dryness test) and in the expansion tube (T
e
)
when the steam supply to the chamber first opens.
Calculate the superheat in C from the following
equation: Superheat = T
e
T
0
, where T
0
is the
boiling point of water at local atmospheric
pressure.
Results
superheat measured in the expansion tube does not
exceed 25C.
Silver solder
Pitot tube
6 mm O/D tubing
150 2
G
1
/4
25 2
2 0.1
Steam
pressure
(kPa)
Bore A
(mm 0.02)
up to 400
up to 500
up to 800
0.8
0.6
0.4
+
0
0
.
6
6
Figure 8 Pitot tube
42
Steam dryness test
3.233 The accurate measurement of the percentage of
moisture content in the steam is difficult, and the
traditional methods, where constant steam flow is
required, are not suitable for sterilizers. This test
should be regarded not as measuring the true
content of moisture in the steam, but as a method
by which the provision of acceptable steam quality
can be demonstrated. Possible sources of excessive
moisture are discussed in paragraph 3.18,
Dryness.
3.234 The test is carried out immediately after the
superheat test.
Apparatus
3.235 A pitot tube is shown in Figure 8. The apparatus is
shown and described in Figure 10. All sizes are
nominal.
3.236 A laboratory balance capable of weighing a load up
to 2 kg with an accuracy of 0.1 g or better.
Method
3.237 If it is not already fitted, fit the pitot tube
concentrically within the steam service pipe as
shown in Figure 10.
3.238 If it is not already fitted, fit the sensor entry gland
to the steam service pipe. Insert a temperature
Temperature sensor fitting
From steam service
To temperature measuring instrument
To sterilizer
250 mm (minimum)
150 2
25 2 40 2
A
+
0
.
6
0
6
1
4

1
Nylon bush
Push fit into
the tube
Suitable fitting for
locating a temperature
sensor into the tube.
To minimise heat transfer
between the fitting and
temperature sensor,
insulation may be
required.
A
Pitot tube
Expansion tube
Expansion tube
Figure 9 Apparatus for superheat test
3 Steam plant
43
sensor through the gland and position it on the
axis of the pipe.
3.239 Connect the rubber tube to the longer of the pipes
in the stopper, place the stopper in the neck of the
vacuum flask, weigh the whole assembly and
record the mass (M
1
).
3.240 Remove the stopper and tube assembly and pour
650 50 mL of cold water (below 27C) into the
flask. Replace the stopper and tube assembly,
weigh the flask and record the mass (M
2
).
3.241 Support the flask close to the pitot and ensure that
the rubber tube and flask are protected from excess
heat and draughts. Do not connect it to the pitot
tube yet.
3.242 Introduce the second temperature sensor through
the shorter of the two pipes in the stopper and into
the water in the flask. Record the temperature of
the water in the flask (T
0
).
3.244 When the steam supply to the chamber first opens,
connect the rubber tube to the pitot discharge and
wrap lagging around it. Arrange the rubber tube to
permit condensate to drain freely into the flask.
Record the temperature in the steam service pipe
(T
0
).
From steam service
250 mm (minimum)
Pitot tube
Temperature sensor
entry gland
Rubber tubing of length 450 50mm
(must be self-draining)
Rubber
bung
assembly
To temperature
measuring
instrument
1-litre
vacuum
flask
To sterilizer
Pipe for thermocouple
and vent
Sample
pipe
9
0

m
m
2
5

m
m
1
5
0

m
m
2
9
0

m
m
Rubber bung assembly
(glass pipes have 6 mm outside diameter)
Figure 10 Apparatus for dryness test
44
3.245 When the temperature of the water in the flask is
approximately 80C, disconnect the rubber tube
from the pitot, agitate the flask so that the
contents are thoroughly mixed and record the
temperature of the water (T
1
).
3.246 Weigh the flask and stopper assembly and record
the mass (M
3
).
3.247 The initial mass of water in the flask is given by
M
w
= M
2
M
1

3.248 The mass of condensate collected is given by
M
c
= M
3
M
2

3.249 Calculate the dryness value of the steam from the
following equation:
Where:
T
0
= initial temperature of the water in the flask
(C);
T
1
= final temperature of the water and condensate
in the flask (C);
T
s
= average temperature of the steam delivered to
the sterilizer (C);
M
w
= initial mass of water in the flask (kg);
M
c
= mass of condensate collected (kg);
L = latent heat of dry saturated steam at
temperature T
s
(kJ kg
1
);
0.24 kJ kg
1
= Effective heat capacity of the
apparatus
Results
following requirements are met:
a. the dryness value is not less than 0.95 unless
only textile loads are being processed, in which
case 0.90 is permissible;
b. throughout the operating cycle, the
temperature measured in the steam service pipe
is within 3C of that measured during the
superheat test.
Operation and maintenance of steam
generators
3.251 Steam generators are steam boilers and are subject
to the Pressure Systems Safety Regulations 2000
(as amended).
3.252 Users should ensure that operation and
maintenance of the generator is carried out
correctly, both to ensure safety and also to
maintain the quality of the steam.
3.253 Steam generators are subject to a written scheme of
examination for pressure vessels.
3.254 Guidance on the design, maintenance, testing and
operation of steam generators can be found in the
Health and Safety Executives INDG436 Safe
management of industrial steam and hot water
boilers.
3.255 The advice of the boiler manufacturer about water
supply, water treatment, blowing down and other
operational practices should be strictly observed.
3.256 Failure to provide adequate supervision, with
consequential inadequate control of water quality
and insufficient blow-down, has resulted in such
severe corrosion of steam generators that in some
cases internal parts have collapsed and operators
have been put in danger.
Operation
3.257 A risk assessment should be undertaken to
establish the level of supervision required. While it
is not acceptable for steam generators to be left
continuously unattended, it is not necessary for an
operator to be present at all times. The amount
and frequency of attention necessary in each case
will depend largely on the nature of the water
supply, water treatment arrangements and the
intensity of use. The operator, who can also be the
sterilizer operator, should be adequately trained.
Maintenance
3.258 Because there is little condensate return to these
steam generators, their feedwater is usually almost
100% make-up, and as a result the concentrations
of dissolved and suspended solids in the boiler
water quickly build up to very high levels. Such
boilers are provided with a blow-down facility to
expel deposits of sludge from the bottom of the
boiler. It is essential that an effective blow-down
regime is established and adhered to. There are
three possibilities:
'
(7
1
7
0
)(4.180
w
0.24)
/0
c
4.18(7
s
7
1
)
/

3 Steam plant
45
a. continuous blow-down sludge is expelled
continuously;
b. automatic intermittent blow-down sludge is
expelled automatically under the control of a
timer or conductivity device;
c. manual intermittent blow-down sludge is
expelled manually under the control of the
operator.
3.259 With manual blow-down there is a risk of affecting
the steam quality if this is undertaken at a time
when there is a high demand for steam. For this
reason manual blow-down should be undertaken
at times of light load, preferably when none of the
sterilizers are operating. Continuous and automatic
blow-down systems should be carefully managed
to ensure they do not affect steam quality.
3.260 Guidance on blow-down can be found in the
Health and Safety Executives PM60 Steam
boiler blow-down systems.
3.261 Generator vessels constructed from stainless steel
will be subject to the same risk of stress-corrosion
cracking encountered in stainless steel sterilizer
chambers. To minimize the risk, the manufacturers
guidance on feedwater quality should be followed.
3.262 A record of all tests and maintenance should be
kept in the machines plant history file.
Pyrogens
Bacterial endotoxins
3.263 Bacterial endotoxins are a group of compounds,
derived predominantly from Gram-negative
bacteria, which give rise to high temperatures and
fever-like reactions when injected into man and
other mammals. This febrile reaction is referred to
as pyrexia and compounds that can cause this
reaction when injected are known as pyrogens.
3.264 Bacterial endotoxins are not the only pyrogenic
compounds but they are by far the most common
and are also of the greatest significance in sterile
product manufacture.
3.265 The majority of bacterial endotoxins causing a
pyrogenic reaction are lipopolysaccharides (LPS)
from the outer membrane of Gram-negative
bacteria.
3.266 Organisms other than Gram-negative bacteria can
give rise to endotoxins. For example fragments of
the cell wall peptidoglycan from haemolytic
streptococci produce a similar pyrogenic reaction.
3.267 Bacterial endotoxins are extremely heat-stable and
are only destroyed after prolonged exposure to
high temperatures (3 h at 180C or 30 min at
250C). They are not destroyed by any of the
sterilization processes commonly employed for
medical devices and medicinal products.
Clinical significance
3.268 In small doses the injection of endotoxins causes
pyrexia (fever), transient leukopenia followed by
leukocytosis, hyperglycaemia, haemorrhagic
necrosis of certain tumours, abortion, altered
resistance to bacterial infection, various circulatory
disturbances and vascular hyperreactivity to
adrenergic drugs. When injected in larger amounts
endotoxins cause shock, usually accompanied by
severe diarrhoea; absorption of endotoxin from the
bowel is a major cause of terminal irreversibility in
haemorrhagic shock.
3.269 Endotoxins appear to cause pyrexia, not directly
but through an endogenous pyrogen released from
polymorphonuclear leukocytes.
3.270 Endotoxins are generally assumed to play a large
role in the vascular, metabolic, pyrogenic and
haematalogic alterations that occur in severe
Gram-negative infections but the evidence is
indirect since, unlike most bacterial exotoxins, no
specific protective antibody is available.
3.271 Subcutaneous injection of microgram quantities of
endotoxins produces a mild inflammatory reaction
but, when the injection is repeated with the same
or a different endotoxin 24 h later, the originally
injected site becomes haemorrhagic within a few
hours. This reaction (the Shwartzman reaction) is
accentuated by the presence of cortisone.
3.272 Many sterile medical devices are intended for use
on wounds where the dermis might have been
breached. The sterile product might thus come
into direct contact with the vascular system and if
endotoxins are present might cause a pyrogenic
reaction.
Detection and measurement
3.273 The classic method of detection of pyrogens in
pharmaceutical products is by measurement of the
temperature rise in rabbits to which the substance
has been administered. This method does not
readily permit assay of the amount of endotoxin
46
present. However, it is sensitive to all pyrogenic
substances, whether or not they are bacterial
endotoxins.
3.274 In-vitro assay, which depends on the gelation of
extracts of lysed blood cells of the horseshoe crab
Limulus polyphemus, can be used quantitatively
and will detect picogram quantities of
lipopolysaccharide (endotoxin) in the LAL test
(limulus amoebocyte lysate). A modification of the
LAL test to provide a chromogenic test has been
made, which allows reading of the endotoxin
concentration by spectrophotometry. A
turbidimetric method, which requires dedicated
capital equipment, is also available as a
quantitative method. Sensitivities as low as
0.001EU mL
1
are available.
3.275 There is considerable variability in endotoxins
derived from different bacterial species and it is
difficult to set limits of permissible amount in
terms of mass per unit volume. The US Food and
Drugs Administration devised a unit of potency,
the endotoxin unit (EU), to overcome this
problem. The units are related to the endotoxin
derived from Escherichia coli assigned by
comparison with a United States Pharmacopeia
(USP) reference endotoxin. The 1st International
Standard for Endotoxin, established in 1986,
consists of lyophilized endotoxin from E. coli
0113:H10:K(-)ve with trehalose (normally
supplied in ampoules containing 14,000 EU). This
or another suitable preparation (such as the
European Pharmacopoeia Biological Reference
Preparation), the activity of which has been
determined in relation to the International
Standard using a gelation method permits
standardisation of the sensitivity of the lysate.
Generation of bacterial endotoxin
3.276 Endotoxins arise, almost without exception, from
the cell wall of Gram-negative bacteria. This is
present both on the surface of the living bacteria
and as persistent fragments of dead bacteria. As
previously noted the endotoxins are thermally very
stable.
3.277 Gram-negative bacteria include a wide range of
organisms, for example:
a. the sheathed bacteria, for example Sphaerotilus
spp., which are large rods in a mucilaginous
sheath found anchored to the substrate in
running water (also called sewage fungus);
b. some 17 genera of budding or stalked bacteria
such as Caulobacter;
c. the aerobic rods and cocci which include:
Pseudomonas spp., which are ubiquitous;
Xanthomonas spp., common plant pathogens;
Halobacterium spp., which live in saturated
brine; Brucella spp.;
d. the facultative anaerobes: Escherichia, indicator
of faecal contamination; Salmonella, Shigella,
intestinal pathogens; Erwinia, plant pathogen;
Enterobacter, Serratia, Proteus, soil and aquatic;
Vibrio, commonly marine aquatic;
e. the obligate anaerobes of the family
Bacteroidaceae, Bacteroides, Fusobacterium.
3.278 These, or any other Gram-negative species, will
inevitably give rise to endotoxins. However there
are other organisms, such as haemolytic
streptococci, where the cell wall peptidoglycan
produces the same reaction as endotoxins from
Gram-negative bacteria.
3.279 The quantity of endotoxin produced per cell varies
from about 4 femtograms (fg) in bacteria growing
in very pure water to as much as 16 fg for those
grown under nutrient-rich conditions. For E. coli,
0.03 EU mL
1
corresponds to approximately
0.003 ng per mL of endotoxin. Allowing that each
cell produces approximately 6 fg of endotoxin then
500 bacteria per mL would give rise to 0.03 EU
mL
1
.
3.280 None of the sterilization processes used routinely
for the preparation of pharmaceuticals, medical
devices or surgical instruments will destroy or
remove endotoxins once they are present. The only
method of control therefore is to prevent the
growth of significant numbers of Gram-negative
bacteria within the product or in any component
or material that directly comes into contact with it.
3.281 Gram-positive bacteria, with the exceptions noted
above, do not produce endotoxins. The Gram-
positive bacteria include organisms such as the
family Micrococcaceae, which contains the genera
Staphylococcus and Micrococcus, and the spore
formers of the genera Bacillus and Clostridium. It is
among these organisms that those species most
resistant to radiation and thermal sterilization are
found.
3 Steam plant
47
Regulatory requirements
3.282 Pharmacopoeial specifications for water include
several different grades of which the two principal
grades are purified water and water for injections
(WFI).
3.283 In the European Pharmacopoeia (EP), WFI is
required to be prepared from potable water or
purified water by distillation in an apparatus of
which the parts in contact with the water are of
neutral glass, quartz or suitable metal and which is
fitted with an effective device to prevent the
entrainment of droplets. The apparatus should
produce water free from pyrogens and to ensure
this correct maintenance is essential. The first
portion of the distillate obtained when the
apparatus begins to function is discarded.
3.284 The United States Pharmacopoeia (USP), however,
permits the use of reverse osmosis for the
preparation of WFI. In all other respects the limits
set, and the test to determine compliance, are
essentially similar.
3.285 USP XXII suggests an aerobic viable count limit of
500 cfu mL
1
for potable water and 100 cfu mL
1

for purified water (although normal practice would
be not to accept >50 cfu mL
1
for purified water).
3.286 WFI (both USP and EP) is required to be free
from pyrogens and there is a specified limit for
bacterial endotoxins of <0.25 EU mL
1
.
3.287 Where a product, such as a wound irrigation
solution, is required under the terms of the
product licence to be non-pyrogenic the
endotoxin standard for WFI would apply even
though the product is not actually for parenteral
administration.
Requirements for steam
3.288 The requirement for parenterally administered
medicinal products to be free from pyrogens is
immediately apparent. It is not always recognised,
however, that a similar requirement exists for
medical devices or that the steam sterilization
process can be a source of pyrogen contamination.
3.289 In the sterilization of solid goods steam in the
sterilizer chamber condenses on the surface of the
goods. This condensation process is necessary to
heat the goods to the required temperature and
provide the moist conditions necessary for rapid
sterilization. At the end of the sterilization stage
the condensate is evaporated from the load by
reducing the pressure in the sterilizer chamber
(drying vacuum) to produce a cooler, dry load.
3.290 Bacterial endotoxin carried in the steam supply
will be deposited with the condensate and tends to
become concentrated on the surface of the goods
when the condensate is evaporated off during the
vacuum drying stage. In consequence, items
intended for use in invasive procedures, or for use
in the preparation or administration of parenteral
products, should be sterilized in a sterilizer that is
supplied with pyrogen-free steam.
3.291 For practical purposes steam for use in sterilizers
might be regarded as pyrogen-free when a
condensed, representative, sample meets the
European Pharmacopoeial standard for Water for
Injections, that is, less than 0.25 EU mL
1
.
3.292 Two factors are of greatest importance in ensuring
that the steam supply is pyrogen-free:
a. the quality of the feedwater to the steam raising
plant, high levels of pyrogens or high bacterial
counts in the feedwater will ensure that limited
carry-over of water as droplets in the steam will
make a significant contribution to the pyrogen
level;
b. the performance of the steam raising plant, in
particular that its design, construction and
mode of operation ensure that there is the
minimum carry-over of entrained droplets of
water.
Summary
3.293 The following key points summarise the topics
discussed above:
most pyrogens are bacterial endotoxins;
endotoxins are lipopolysaccharides formed by
the cell wall of Gram-negative bacteria;
endotoxins are very stable molecules and are
not destroyed by normal sterilization processes;
90% of the bacteria growing in purified waters
are Gram-negatives;
pyrogen testing was traditionally done by
administering the substance to rabbits and
observing whether there is a temperature rise;
endotoxin testing may be done in vitro using
the limulus amoebocyte lysate (LAL) test;
the endotoxin limit for WFI (EP) is <0.25 EU
mL
1
;
48
endotoxins are also of significance for medical
devices, surgical equipment and equipment
used to prepare parenteral medicinal products;
if the steam when condensed is within the
endotoxin limit for WFI (EP) it might be
regarded as pyrogen-free;
control of pyrogens in the steam is achieved by
appropriate control of the boiler and its
feedwater.
Tests for steam
3.294 This section contains procedures for the testing of
steam condensate samples. The tests for chemical
purity and the test for bacterial endotoxins are
derived from the tests for Water for Injections in
the British Pharmacopoeia. A procedure for the
field measurement of electrical conductivity is also
given.
Laboratory tests for chemical purity
3.295 Tests should be performed as defined in the
European Pharmacopoeia.
Field test for pH and electrical conductivity
3.296 The only tests of steam condensate or feedwater
that can be reliably carried out on site are tests for
electrical conductivity and pH.
3.297 A portable conductivity meter is required, accurate
to 1% over a range that includes 130 S cm
1

with a resolution of 0.1 S cm
1
. It should be
temperature-compensated over the range 040C,
so that it gives readings standardised to 25C. The
instrument should be designed to measure the
conductivity of very pure water.
3.298 A portable pH meter will be required, accurate to
1% over a range that includes 57 with a
resolution of 0.1 pH units. It should be
temperature-compensated over the range 040C,
so that it gives readings standardised to 25C. The
instrument should be designed to measure the
conductivity of very pure water.
3.299 Commercially available meters usually have
temperature compensation set at 2% per C either
as standard or as a default value. The
compensation effect is often user-adjustable over
the range 05% per C, but unless there are
unusual local circumstances (such as a particularly
ubiquitous contaminant) the temperature
compensation value should be set at 2% per C.
3.300 Several standard pH and conductivity reference
solutions are also required, preferably with pH and
conductivity values that bracket the expected
value. A range of such reference solutions,
including pure water reference solutions (also
known as absolute water) is available commercially,
standardised at 25C and traceable to national
standard reference materials. The reference
solutions should be allowed to equilibrate to room
temperature in the area in which the tests will be
conducted.
3.301 Determine steam condensate pH using a suitably
calibrated pH meter.
3.302 Wash the meter probe with purified water BP or
with the sample water. Measure the conductivity
and pH of the reference solutions. Use the results
to calibrate the meter in accordance with the
manufacturers instructions.
3.303 Measure the temperature of the sample. For
effective temperature compensation, this test is
best carried out with both sample and reference
solutions near a temperature of 25C. If the
sample is hotter, allow it to cool until the
temperature is approximately 25C.
3.304 Wash the meter probe either with purified water
BP. Measure the conductivity of the sample.
measured conductivity:
a. does not exceed the value specified for steam in
Table 5;
b. is consistent within experimental errors with
the value measured during validation.
3.306 If the conductivity has risen substantially from the
value determined during validation, the cause
should be identified and corrected.

CFPP 01-01 Part C Steam Sterilization

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CFPP 01-01 Management and decontamination of surgical instruments: Part C Steam sterilization

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